Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.

Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.

The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Sentinel Lymph Node
• Intervention / Treatment: Drug: Indocyanine green

Detailed Description

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. But identification of metastatic LNs within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. Recently, indocyanine green (ICG) and methylene blue are commonly used in clinical practice. ICG as a fluorescent dyes, has effectiveness in mapping SLNs during surgery. Surgeons can follow the fluorescence display to detect SLN, and simultaneously capture real-time fluorescent video images. Several other groups has been demonstrated that the usage of ICG fluorescent surgical navigation system to detect SLNs in breast cancer patients is technically feasible. But no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. Deep learning (DL) artificial intelligence (AI) algorithms in medical imaging are rapidly expanding.

In this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. Furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Xueqi Fan, MD; Phone Number: 19859202604; Email: fanxq@stu.xmu.edu.cn

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine
      • Contact: Xueqi Fan, MD; Phone Number: 19859202604; Email: fanxq@stu.xmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from Xiang'An Hospital of Xiamen University, between November 30, 2022, and November 30, 2024.

Description

Inclusion Criteria:

• Patients aged 18-70 years female.
• The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer.
• No clinical examination of suspicious axillary lymph node-positive.
• Preoperative clinical or radiologic evidence without distant metastases (M0).
• The patient has good compliance with the planned protocol during the study and signed informed consent.

Exclusion Criteria:

• Pregnancy, breastfeeding.
• Allergy to ICG.
• Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer.
• Psychiatric or cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Indocyanine green; Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument.	Drug: Indocyanine green; Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Other Names: ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of lymph node metastasis	The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.	Participants will be followed for the duration of hospital stay, an expected average of 3 months

Collaborators and Investigators

• Sponsor: Xiang'an Hospital of Xiamen University
• Investigators: Principal Investigator: Xueqi Fan, MD, School of Medicine, Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Xiang'an Hospital of XMU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No